60" CENTURY STERILIZER
Received Mar 12, 2026 · Event occurred Feb 10, 2026
Report 3005899764-2026-00020 · MDR key 24582297
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND THAT THE DOOR SEAL REQUIRED REPLACEMENT. DURING THE TIME OF THE REPORTED EVENT THE DOOR SEAL PREVENTED A PROPER SEALING RESULTING IN THE STEAM LEAK. THE TECHNICIAN REPLACED THE DOOR SEAL, TESTED THE FUNCTION AND OPERATION OF THE STERILIZER, CONFIRMED IT TO BE OPERATING TO SPECIFICATION AND RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A BOWIE DICK TEST CYCLE, STEAM LEAKED FROM THE TOP DOOR SEAL OF THEIR 60" CENTURY STERILIZER. NO REPORT OF INJURY.